Tag Archives: Asco

Medscape (2/4, Chustecka) reports that “immunotherapy has been chosen as the ‘clinical cancer advance of the year’ by the American Society of Clinical Oncology (ASCO) in its Clinical Cancer Advances 2016 report.” In the introduction to the report, ASCO president Julie Vose, MD, writes, “No recent advance has been more transformative than the rise of immunotherapy, particularly over this past year.”

MedPage Today (2/4, Bankhead) reports, “Published online in the Journal of Clinical Oncology to coincide with World Cancer Day, the report calls on Congress to continue its ‘sustained robust federal funding for cancer research,’ characterized as pivotal to future progress in cancer.”

Healio (2/4, Kelsall) reports that “during a press conference held on Capitol Hill in Washington, D.C., on World Cancer Day,” Dr. Vose said, “In the era of precision medicine and molecular medicine, we can select treatment based on the genomic profiling of each patient and each tumor. Cancer immunotherapy uses the body’s own immune system to fight cancer, which is something that those of us in cancer research have been dreaming about for years, and which has finally come to fruition.”

This will have significant implications for patients who have tests performed by companies/laboratories that bring to market to their own tests they have validated and market for clinical testing. FDA, while it has always reserve the right to do so, has largely not regulated laboratory-developed tests. This appears to be changing with some support by clinical organizations. Further discussions with the FDA, companies, laboratories and clinical diagnostics organizations are going to be required to balance patient safety, quality assurance and access for patients to important tests that are coming to market.

Stat (11/18, Fong) reports in continuing coverage that the Food and Drug Administration “is stepping up its plans to regulate all medical laboratory testing,” as a report released by the agency this week found 20 examples of laboratory-developed tests that may have harmed patients. Dr. Peter Lurie, FDA associate commissioner for public health strategy, said in a blog post, “FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.”

Modern Healthcare (11/18, Dickson) reports that Lurie also said, “These tests may suggest that a patient doesn’t have a disease or condition, when in fact they do.” Dr. Patrick Conway, the chief medical officer of the Center for Medicaid and Medicare Services, the agency that currently has jurisdiction over the lab-developed tests, said, “The CMS does not have a scientific staff capable of determining whether a test is difficult to successfully carry out or likely to prove detrimental to a patient if carried out improperly.” Medical societies, including the American Society of Clinical Oncology, support FDA regulation of lab-developed tests. Fortune (11/18) and The Scientist (11/18, Vence) also covered the story.

The Philadelphia Inquirer (11/16, Bauers) carries an interview with Dr. Adam Dicker, professor and chair of the Department of Radiation Oncology at Thomas Jefferson University’s Sidney Kimmel Medical College, who is a coauthor of guidelines developed by the American Society of Clinical Oncology “to help physicians, patients, and their families assess efficacy, toxicity, and costs of the various treatment options.” Dicker said, “The good news in oncology is that…there are now a number of new drugs that have clinical benefit.” He explained that ASCO organized a panel to “look at the best-quality data available” in order to calculate cost of treatment and expected benefits. The panel produced “a very useful visual called ‘Evidence Blocks’ that play a pivotal role when having a conversation with a patient and their family.”